Breast CancerNCT06857747
Disitamab Vedotin in Combination with Metronomic Chemotherapy in Advanced HER2-expressing Breast Cancer.
A study testing Capecitabine, Vinorelbine and Etoposide in people with Breast Cancer, run by QIAO LI.
Trial summary
This study aims to explore the efficacy of Disitamab vedotin in combination with metronomic chemotherapy in advanced breast cancer. By integrating the rapid onset of action of Disitamab vedotin with the characteristics of metronomic chemotherapy, the study seeks to further improve patients' response rates and enhance… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Capecitabine, Vinorelbine and Etoposide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily agree to participate in the study and sign an informed consent form;
- Male or female, aged ≥18 years;
- Expected survival period ≥12 weeks;
- Patients with histologically confirmed HER2-positive advanced breast cancer;
- Measurable lesions as defined by RECIST v1.1 criteria;
- Ability to provide tumor samples for HER2 testing from the primary or metastatic lesion:
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- HER2-positive definition: confirmed by immunohistochemistry (IHC) score of 3+ or 2+/fish+;
- HER2 low expression definition: confirmed by IHC score of 2+/1+;
- Previous treatment requirements:
- HER2 3+: previously received at least 1 line of treatment;
- HER2 low HR+: progression after prior endocrine therapy and <3 lines of chemotherapy;
- HER2 low HR-: <3 lines of chemotherapy in the past;
- ECOG performance status score 0-1;
- Adequate cardiac, bone marrow, liver, and renal function (according to the normal values of the research center):
- Hematologic criteria:
- Hemoglobin (Hb) ≥ 100 g/L;
- Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L;
- Platelet count (PLT) ≥ 100 × 10^9/L;
- Biochemical criteria:
- For patients without liver metastases, ALT and AST ≤ 3 × ULN, serum total bilirubin ≤ 1.5 × ULN;
- For patients with liver metastases, ALT and AST ≤ 5 × ULN, serum total bilirubin ≤ 3 × ULN;
- Serum creatinine (Cr) ≤ 1.5 ULN or estimated creatinine clearance > 60 ml/min (Cockcroft-Gault formula); Urine analysis results showing urinary protein (UPRO) < 2+ or 24-hour urinary protein < 1g;
- Cardiac function:
- New York Heart Association (NYHA) class < 3;
- Echocardiography showing left ventricular ejection fraction (LVEF) ≥ 50%;
- For female subjects: should be surgically sterilized, postmenopausal patients, or agree to use at least one medically approved contraceptive method (such as intrauterine device [IUD], contraceptive pills, or condoms) during the study treatment period and for at least 6 months after the end of the study treatment. Serum or urine pregnancy test must be negative within 7 days before enrollment and must not be lactating. Male subjects should agree to use at least one medically approved contraceptive method (such as condoms, abstinence, etc.) during the study treatment period and for at least 6 months after the end of the study treatment;
- Willing and able to comply with the trial and follow-up procedures.
Who cannot join
- Patients with central nervous system metastases and/or carcinomatous meningitis. Patients who have undergone treatment for brain metastases may be considered for participation in this study provided that their condition has remained stable for at least 3 months, there is no evidence of disease progression on imaging performed within 4 weeks prior to the initiation of study treatment, all neurological symptoms have returned to baseline levels, there is no evidence of new or enlarging brain metastases, and there has been a discontinuation of radiation, surgery, or corticosteroid therapy for at least 28 days prior to the initiation of study treatment. This exception does not apply to carcinomatous meningitis, which should be excluded regardless of clinical stability.
- Toxicities from prior anti-tumor therapy have not recovered to Common Terminology Criteria for Adverse Events (CTCAE) grade 0-1 (except for grade 2 alopecia).
- Major surgery within 4 weeks prior to the start of study treatment and incomplete recovery.
- Clinically significant pleural effusion or ascites requiring symptomatic treatment.
- Receipt of attenuated live vaccines within 30 days prior to or anticipated during the study period.
- Occurrence of a severe thromboembolic event or cerebrovascular accident within 1 year prior to study treatment initiation, such as deep vein thrombosis (excluding asymptomatic and non-interventional muscle venous thrombosis), pulmonary embolism, stroke, intracranial hemorrhage, myocardial infarction, except for asymptomatic and clinically non-interventional lacunar infarction.
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- Heart failure categorized as New York Heart Association (NYHA) class 3 or higher.
- Presence of systemic diseases judged by the investigator to be unstable, including diabetes, hypertension, cirrhosis, interstitial pneumonia, obstructive lung disease, etc.
- Active autoimmune disease requiring systemic therapy within 2 years prior to study treatment initiation (such as use of immunomodulatory drugs, corticosteroids, or immunosuppressants), with permitted alternative therapies (e.g., thyroid hormone, insulin, or physiological corticosteroid replacement therapy for renal or pituitary insufficiency).
- Severe infection within 4 weeks prior to the first dose of study treatment (e.g., requiring intravenous administration of antibiotics, antifungals, or antiviral drugs), or occurrence of unexplained fever >38.5°C during the screening period or within 3 weeks prior to the first dose of study treatment.
- Active autoimmune disease or immunodeficiency, or a history thereof, including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, rheumatoid arthritis, inflammatory bowel disease, pituitary inflammation, vasculitis, nephritis, etc. Exceptions include patients with a history of autoimmune thyroiditis who receive thyroid hormone replacement therapy or patients with type 1 diabetes whose blood glucose is controlled with insulin therapy.
- Active or poorly controlled severe infections, including:
- Human Immunodeficiency Virus (HIV) (positive for HIV1/2 antibodies);
- Active hepatitis B (positive for HBsAg or abnormal liver function with HBV DNA >2000IU/ml);
- Active hepatitis C (positive for HCV antibodies or HCV RNA ≥103 copies/ml with abnormal liver function);
- Active tuberculosis;
- Other uncontrollable active infections (CTCAE V5.0 > grade 2);
- Subjects who have received or plan to receive solid organ or hematopoietic stem cell transplantation during the study period (excluding corneal transplantation);
- Subjects with a history of other malignant tumors within five years (except completely treated in situ cervical cancer, basal cell carcinoma, or squamous cell carcinoma of the skin);
- Currently participating in interventional clinical research treatment or received other investigational drugs or investigational device therapy within 4 weeks prior to the first dose of study treatment. Subjects have not fully recovered from any intervention-induced toxicities and/or complications (i.e., ≤ grade 1 or returned to baseline, excluding fatigue or alopecia) before the first dose of study treatment;
- Clear history of allergy or potential allergy or intolerance to investigational drugs and similar biological agents;
- History of substance abuse involving psychotropic drugs and unable to abstain, or presence of psychiatric disorders;
- Other conditions determined by the investigator to increase the risk associated with study participation or investigational drug, and according to the investigator's judgment, may render the patient unsuitable for study enrollment.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: An Exploratory, Multicenter, Multi-cohort Phase II Clinical Trial of Disitamab Vedotin in Combination with Metronomic Chemotherapy in Advanced HER2-expressing Breast Cancer.
This study aims to explore the efficacy of Disitamab vedotin in combination with metronomic chemotherapy in advanced breast cancer. By integrating the rapid onset of action of Disitamab vedotin with the characteristics of metronomic chemotherapy, the study seeks to further improve patients' response rates and enhance their quality of life, building upon the extension of patient survival.
Read the detailed description
Disitamab vedotin is a novel, cleavable antibody-drug conjugate (ADC) targeting HER2, with prior research indicating its efficacy in HER2-positive and low-expressing breast cancer. Patients with advanced breast cancer often have compromised general conditions, and some may have received conventional intensity chemotherapy, making further treatment challenging. Metronomic chemotherapy, characterized by lower drug doses, reduced intensity, continuous administration, and fewer adverse effects, offers the potential to improve quality of life and prolong survival for these patients. This study aims to explore the efficacy of disitamab vedotin in combination with metronomic chemotherapy in advanced breast cancer. By combining the rapid onset of action of disitamab vedotin with the characteristics of metronomic chemotherapy, the study seeks to not only extend patient survival but also enhance response rates and improve quality of life.
- Conditions
- Breast Cancer
- Being tested
- Capecitabine, Vinorelbine, Etoposide
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapecitabineDrug
metronomic capecitabine, 500 mg, tid， po
VinorelbineDrug
metronomic vinorelbine, 40mg/d, TIW1, po
EtoposideDrug
metronomic etoposide, 50mg/d, po
| Study group | Role | What they receive |
|---|---|---|
| HER2-positive advanced breast cancer | Experimental | Patients will receive disitamab vedotin combining with metronomic chemotherapy in a 3-week treatment cycle. Receives: Drug: Capecitabine; Drug: Vinorelbine; Drug: Etoposide |
| HER2 2+/1+ expressed in IHC advanced breast cancer | Experimental | Patients will receive disitamab vedotin combining with metronomic chemotherapy in a 3-week treatment cycle. Receives: Drug: Capecitabine; Drug: Vinorelbine; Drug: Etoposide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival，PFS
To evaluate the efficacy of anti-tumor
Measured: 21 or 28 days after the last dose
Secondary outcomes (5)
Overall survival，OS
To evaluate the efficacy of anti-tumor
Measured: 1 year after the last dose
Objective response rate，ORR
To evaluate the efficacy of anti-tumor
Measured: 21 or 28 days after the last dose
Disease Control Rate，DCR
To evaluate the efficacy of anti-tumor
Measured: 21 or 28 days after the last dose
Duration of Response，DoR
To evaluate the efficacy of anti-tumor
Measured: 21 or 28 days after the last dose
Safety: Hematologic and non-hematologic toxicity (NCI CTCAE v5.0)
To identify the incidence of AE and SAE in clinical trial
Measured: rom the initiation of the first dose to 21 or 28 days after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start1 Mar 2025 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- QIAO LI
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, QIAO LI, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Investigators
- Qiao Li, Dr., Study director, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06857747
- Sponsor's protocol ID
- NCC4532
- Status last verified
- Mar 2024
- First submitted
- 27 Feb 2025
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory, Multicenter, Multi-cohort Phase II Clinical Trial of Disitamab Vedotin in Combination with Metronomic Chemotherapy in Advanced HER2-expressing Breast Cancer.
- ClinicalTrials.gov ID
- NCT06857747
- Acronym / sponsor ID
- NCC4532
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- QIAO LIUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 4 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to explore the efficacy of Disitamab vedotin in combination with metronomic chemotherapy in advanced breast cancer. By integrating the rapid onset of action of Disitamab vedotin with the characteristics of metronomic chemotherapy, the study seeks to further improve patients' response rates and enhance their quality of life, building upon the extension of patient survival.
Detailed description
Disitamab vedotin is a novel, cleavable antibody-drug conjugate (ADC) targeting HER2, with prior research indicating its efficacy in HER2-positive and low-expressing breast cancer. Patients with advanced breast cancer often have compromised general conditions, and some may have received conventional intensity chemotherapy, making further treatment challenging. Metronomic chemotherapy, characterized by lower drug doses, reduced intensity, continuous administration, and fewer adverse effects, offers the potential to improve quality of life and prolong survival for these patients. This study aims to explore the efficacy of disitamab vedotin in combination with metronomic chemotherapy in advanced breast cancer. By combining the rapid onset of action of disitamab vedotin with the characteristics of metronomic chemotherapy, the study seeks to not only extend patient survival but also enhance response rates and improve quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HER2-positive advanced breast cancer | Experimental | Drug: Capecitabine, Drug: Vinorelbine, Drug: EtoposidePatients will receive disitamab vedotin combining with metronomic chemotherapy in a 3-week treatment cycle. |
| HER2 2+/1+ expressed in IHC advanced breast cancer | Experimental | Drug: Capecitabine, Drug: Vinorelbine, Drug: EtoposidePatients will receive disitamab vedotin combining with metronomic chemotherapy in a 3-week treatment cycle. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Voluntarily agree to participate in the study and sign an informed consent form;
- Male or female, aged ≥18 years;
- Expected survival period ≥12 weeks;
- Patients with histologically confirmed HER2-positive advanced breast cancer;
- Measurable lesions as defined by RECIST v1.1 criteria;
Key exclusion criteria (23 listed)
- Patients with central nervous system metastases and/or carcinomatous meningitis. Patients who have undergone treatment for brain metastases may be considered for participation in this study provided that their condition has remained stable for at least 3 months, there is no evidence of disease progression on imaging performed within 4 weeks prior to the initiation of study treatment, all neurological symptoms have returned to baseline levels, there is no evidence of new or enlarging brain metastases, and there has been a discontinuation of radiation, surgery, or corticosteroid therapy for at least 28 days prior to the initiation of study treatment. This exception does not apply to carcinomatous meningitis, which should be excluded regardless of clinical stability.
- Toxicities from prior anti-tumor therapy have not recovered to Common Terminology Criteria for Adverse Events (CTCAE) grade 0-1 (except for grade 2 alopecia).
- Major surgery within 4 weeks prior to the start of study treatment and incomplete recovery.
- Clinically significant pleural effusion or ascites requiring symptomatic treatment.
- Receipt of attenuated live vaccines within 30 days prior to or anticipated during the study period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Capecitabinemetronomic capecitabine, 500 mg, tid， po | Drug | HER2 2+/1+ expressed in IHC advanced breast cancer, HER2-positive advanced breast cancer |
| Vinorelbinemetronomic vinorelbine, 40mg/d, TIW1, po | Drug | HER2 2+/1+ expressed in IHC advanced breast cancer, HER2-positive advanced breast cancer |
| Etoposidemetronomic etoposide, 50mg/d, po | Drug | HER2 2+/1+ expressed in IHC advanced breast cancer, HER2-positive advanced breast cancer |
Primary outcome
Progression-free survival，PFS
Time frame: 21 or 28 days after the last dose
To evaluate the efficacy of anti-tumor
5 secondary outcomes
Overall survival，OS
Time frame: 1 year after the last dose
Objective response rate，ORR
Time frame: 21 or 28 days after the last dose
Disease Control Rate，DCR
Time frame: 21 or 28 days after the last dose
Duration of Response，DoR
Time frame: 21 or 28 days after the last dose
Safety: Hematologic and non-hematologic toxicity (NCI CTCAE v5.0)
Time frame: rom the initiation of the first dose to 21 or 28 days after the last dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qiao Li, Dr. study director
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Questions about this trial
What is this clinical trial studying?
A study testing Capecitabine, Vinorelbine and Etoposide in people with Breast Cancer, run by QIAO LI.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qiao Li, Dr. (+086-87788820, liqiaopumc@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival，PFS (time frame: 21 or 28 days after the last dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025.